MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ADJUSTABLE PIN COLLET (2.0-3.2MM)

Catalog Number	4100126000
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The device had metal debris coming out of it during a service evaluation at the manufacturer facility.  there were no adverse consequences related to this event.

• Brand Name: ADJUSTABLE PIN COLLET (2.0-3.2MM)
• Common Device Name: ADJUSTABLE PIN COLLET (2.0-3.2MM)
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8400614
• Report Number: 0001811755-2019-00774
• Device Sequence Number: 1976068
• Product Code: HRX
• UDI-Device Identifier: 04546540377982
• UDI-Public: 04546540377982
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K943323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 4100126000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1